Why a patient paid a $285 copay for a $40 drug

Posted on August 19, 2018 by Pharmaciststeve

https://www.pbs.org/newshour/health/why-a-patient-paid-a-285-copay-for-a-40-drug

Two years ago Gretchen Liu, 78, had a transient ischemic attack — which experts sometimes call a “mini stroke” — while on a trip to China. After she recovered and returned home to San Francisco, her doctor prescribed a generic medication called telmisartan to help manage her blood pressure.

Liu and her husband Z. Ming Ma, a retired physicist, are insured through an Anthem Medicare plan. Ma ordered the telmisartan through Express Scripts, the company that manages pharmacy benefits for Anthem and also provides a mail-order service.

The copay for a 90-day supply was $285, which seemed high to Ma.

“I couldn’t understand it — it’s a generic,” said Ma. “But it was a serious situation, so I just got it.”

A month later, Ma and his wife were about to leave on another trip, and Ma needed to stock up on her medication. Because 90 days hadn’t yet passed, Anthem wouldn’t cover it. So during a trip to his local Costco, Ma asked the pharmacist how much it would cost if he got the prescription there and paid out of pocket.

The pharmacist told him it would cost about $40.

“I was very shocked,” said Ma. “I had no idea if I asked to pay cash, they’d give me a different price.”

Ma’s experience of finding a copay higher than the cost of the drug wasn’t that unusual. Insurance copays are higher than the cost of the drug about 25 percent of the time, according to a study published in March by the University of Southern California’s Schaeffer Center for Health Policy and Economics.

USC researchers analyzed 9.5 million prescriptions filled during the first half of 2013. They compared the copay amount to what the pharmacy was reimbursed for the medication and found in the cases where the copay was higher, the overpayments averaged $7.69, totaling $135 million that year.

USC economist Karen Van Nuys, a lead author of the study, had her own story of overpayment. She discovered she could buy a one-year supply of her generic heart medication for $35 out of pocket instead of $120 using her health insurance.

Van Nuys said her experience, and media reports she had read about the practice, spurred her and her colleagues to conduct the study. She had also heard industry lobbyists refer to the practice as “outlier.”

“I wouldn’t call one in four an ‘outlier practice,’” Van Nuys said.

“You have insurance because your belief is, you’re paying premiums, so when you need care, a large fraction of that cost is going to be borne by your insurance company,” said Geoffrey Joyce, a USC economist who co-authored the study with Van Nuys. “The whole notion that you are paying more for the drug with insurance is just mind boggling, to think that they’re doing this and getting away with it.”

Graphic by Lisa Overton

Joyce told PBS NewsHour Weekend the inflated copays could be explained by the role in the pharmaceutical supply chain played by pharmacy benefit managers, or PBMs. He explained that insurers outsource the management of prescription drug benefits to pharmacy benefit managers, which determine what drugs will be covered by a health insurance plan, and what the copay will be. “PBMs run the show,” said Joyce.

In the case of Express Scripts, the company manages pharmacy benefits for insurers and also provides a prescription mail-delivery service.

Express Scripts spokesperson Brian Henry confirmed to PBS NewsHour Weekend the $285 copay that Ma paid in 2016 for his wife’s telmisartan was correct, but didn’t provide an explanation as to why it was so much higher than the $40 Costco price. Henry said that big retailers like Costco sometimes offer deep discounts on drugs through low-cost generics programs.

USC’s Geoffrey Joyce said it is possible that Costco negotiated a better deal on telmisartan from the drug’s maker than Express Scripts did, and thus could sell it for cheaper. But, he said, the price difference, $285 versus $40, was too large for this to be the likely explanation.

Joyce said it is possible another set of behind-the-scenes negotiations between the pharmacy benefit managers and drug makers played a role. He explained that drug manufacturers will make payments to pharmacy benefit managers called “rebates.”

Rebates help determine where a drug will be placed on a health plan’s formulary. Formularies often have “tiers” that determine what the copay will be, with a “tier one” drug often being the cheapest, and the higher tiers more expensive.

Pharmacy benefit managers usually take a cut of the rebate and then pass them on to the insurer. Insurers say they use use the money to lower costs for patients.

Joy said a big rebate to a pharmacy benefit manager can mean placement on a low tier with a low copayment, which helps drives more patients to take that drug.

In the case of Ma’s telmisartan, Express Scripts confirmed to PBS NewsHour Weekend that the generic drug was designated a “nonpreferred brand,” which put it on the plan’s highest tier with the highest copay.

Joyce said sometimes pharmacy benefit managers try to push customers to take another medication for which it had negotiated a bigger rebate. “It’s financially in their benefit that you take the other drug,” said Joyce. “But that’s of little consolation to the person who just goes to the pharmacy with a prescription that their physician gave them.”

But Joyce said the pharmacy benefit managers also profit when collecting copays that are higher than the cost of the drug.

In recent years, the industry has taken a lot of heat from the media and elected officials over a controversial practice called “clawbacks.” This happens when a pharmacist collects a copay at the cash register that’s higher than the cost of the drug, and the pharmacy benefit manager takes most of the difference.

Examples of clawbacks by PBS NewsHour on Scribd

The three largest pharmacy benefit managers – Express Scripts, CVS Caremark, and OptumRx – all told PBS NewsHour Weekend they do not engage in clawbacks.

But Howard Jacobson, a pharmacist at Rockville Centre Pharmacy in Long Island, NY, showed PBS NewsHour Weekend several recent examples of clawbacks. In one instance, Howardson acquired a dose of the generic diabetes Metformin for $1.61. He said if a patient paid out-of-pocket, he likely would sell if for $4. But in a recent transaction, the pharmacy benefit manager told Jacobson to collect a $10.84 copay from the patient, and it took back $8.91.

In the case of Z. Ming Ma and his wife Gretchen Liu, there was no pharmacist involved, because they purchased the medication directly from Express Scripts.

Express Scripts’ Brian Henry reiterated to PBS NewsHour Weekend that the company does not engage in clawbacks and opposes the practice. And he also blamed the health insurer, Anthem, for Ma’s high copay. “Anthem has its own Pharmacy and Therapeutics committee that evaluates placement of drugs on the formulary based on their own clinical and cost review – thus setting their own formulary and pricing,” Henry said in an email.

But Lori McLaughlin, a spokesperson for Anthem, pointed the finger back at Express Scripts. “Anthem currently contracts with Express Scripts for pharmacy benefit manager services and under that agreement Express Scripts provides the drug pricing,” she said in a statement. “Anthem is committed to ensuring consumers have expanded access to high-quality, affordable health care which includes access to prescription drugs at a reasonable price.”

McLaughlin also pointed to a lawsuit filed in March 2016 by Anthem against Express Scripts, for, she said, “breach of its obligation to provide competitive pharmacy pricing.”

As for Express Scripts’ contention that it doesn’t engage in clawbacks, USC’s Karen Van Nuys said it’s a matter of semantics. “Whenever the copay is higher than the cash price, and the difference isn’t reimbursed to the patient, someone else must be pocketing the difference,” Van Nuys said. “Maybe it isn’t technically called a clawback, but the principle is the same.”

So what’s a patient to do? Websites like GoodRx and WellRx can help consumers find the best prices at local pharmacies. They provide coupons and savings cards for certain drugs as well as out-of-pocket price information, which could be less than a copay.

It’s not always better to pay out-of-pocket, even if it’s cheaper. Patients need to look at the terms of their insurance plans and do the math.If a patient has a high deductible, it might make more sense in the long-run to pay the higher price and use up the deductible so insurance kicks in sooner.

Z. Ming Ma said he does find the Express Scripts home delivery service convenient. But he wasn’t happy about the price of his wife’s medication, and is glad he found another way to buy it.

“You have no choice, you can’t bargain,” he said. “I knew I wasn’t going to win.”

This story has been updated to reflect that Gretchen Liu is 78 years old.

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Reporters seeks out interviewee(s) that fits the story/conclusion that they want ?

Posted on August 19, 2018 by Pharmaciststeve

What the media gets wrong about opioids

https://www.cjr.org/covering_the_health_care_fight/what-the-media-gets-wrong-about-opioids.php

After Jillian Bauer-Reese created an online collection of opioid recovery stories, she began to get calls for help from reporters. But she was dismayed by the narrowness of the requests, which sought only one type of interviewee.

“They were looking for people who had started on a prescription from a doctor or a dentist,” says Bauer-Reese, an assistant professor of journalism at Temple University in Philadelphia. “They had essentially identified a story that they wanted to tell and were looking for a character who could tell that story.”

Although this profile doesn’t fit most people who become addicted, it is typical in reporting on opioids. Often, stories focus exclusively on people whose use started with a prescription; take this, from CNN (“It all started with pain killers after a dentist appointment.”), and this, from New York’s NBC affiliate (“He started taking Oxycontin after a crash.”)

Alternatively, reporters downplay their subjects’ earlier drug misuse to emphasize the role of the medical system, as seen in this piece from the Kansas City Star. The story, headlined “Prescription pills; addiction ‘hell,’” features a woman whose addiction supposedly started after surgery, but only later mentions that she’d previously used crystal meth for six months.

The “relatable” story journalists and editors tend to seek—of a good girl or guy (usually, in this crisis, white) gone bad because pharma greed led to overprescribing—does not accurately characterize the most common story of opioid addiction. Most opioid patients never get addicted and most people who do get addicted didn’t start their opioid addiction with a doctor’s prescription. The result of this skewed public conversation around opioids has been policies focused relentlessly on cutting prescriptions, without regard for providing alternative treatment for either pain or addiction.

While some people become addicted after getting an opioid prescription for reasons such as a sports injury or wisdom teeth removal, 80 percent start by using drugs not prescribed to them, typically obtained from a friend or family member, according to surveys conducted for the government’s National Household Survey on Drug Use and Health. Most of those who misuse opioids have also already gone far beyond experimentation with marijuana and alcohol when they begin: 70 percent have previously taken drugs such as cocaine or methamphetamine.

Conversely, a 2016 review published in the New England Journal of Medicine and co-authored by Dr. Nora Volkow, director of the National Institute on Drug Abuse, put the risk of new addiction at less than 8 percent for people prescribed opioids for chronic pain. Since 90 percent of all addictions begin in the teens or early 20s, the risk for the typical adult with chronic pain who is middle aged or older is actually even lower.  

This does not in any way absolve the pharmaceutical industry. Companies like Purdue Pharma, the maker of Oxycontin, profited egregiously by minimizing the risks of prescribing in general medicine. Purdue also lied about how Oxycontin’s effects last (a factor that affects addiction risk) and literally gave salespeople quotas to push doctors to push opioids.

The industry flooded the country with opioids and excellent journalism has exposed this part of the problem. But journalists need to become more familiar with who is most at risk of addiction and why—and to understand the utter disconnect between science and policy—if we are to accurately inform our audience.

The innocent victim narrative

The reporters who called Bauer-Reese were not ill-intentioned in seeking the most sympathetic addiction stories; it is genuinely altruistic to want to portray those who are suffering in a way that is most likely to move readers and viewers to act compassionately. But such cases can have an unintended side effect: highlighting “innocent” white people whose opioid addiction seems to have begun in a doctor’s office sets up a clear contrast with the “guilt” of people whose addiction starts on the streets.  

This is a result of racist drug policies that began decades ago. The war on drugs declared by Richard Nixon in 1971 was part of the Republican “Southern strategy,” which used code words like “drugs” “crime,” and “urban” to signal racist white voters that the party was on their side. When Ronald Reagan doubled down harsh law enforcement during the crack years, he merely intensified that strategy.

Rather than skeptically investigating, however, members of the media enlisted themselves as happy drug warriors throughout the 1980s and ’90s. Sensational stories focused on crack and its users as the cause of the problem, frequently ignoring that addiction hits hardest in communities facing high unemployment, de-industrialization, cuts in benefits, and loss of hope. In 1986, for example, promoting his documentary 48 Hours on Crack Street, CBS anchor Dan Rather intoned, “Tonight, CBS News takes you to the streets, to the war zone for an unusual two hours of hands-on horror.”  Or here’s The New York Times in 1991, “Crack Hits Chicago, Along with a Wave of Killing,” and in 1994, “Crack Means Power, and Death, to Soldiers in Street Wars.”

Now that the problem is seen as “white,” however, socioeconomic factors and other reasons that people turn to drugs are more commonly discussed. The result is that today’s white drug users are portrayed as inherently less culpable than the black people who were caught up in the crack epidemic of the ’80s and ’90s.

Craig Reinarman, professor of sociology emeritus at the University of California, Santa Cruz, has documented biased coverage of addiction since before the crack era. “Now that the iconic user is white and middle class, the answer is no longer a jail cell for every addict, it’s a treatment bed,” he says. The biased coverage ends up perpetuating a public perception that some drug use, usually by African Americans, is criminal while other drug use, usually by white people, is not.

Criminalization still deeply affects our sympathy for people with opioid addiction. This headline recently appeared in the Times: “Injecting Drugs Can Ruin a Heart. How Many Second Chances Should a User Get?” Is that a question reporters would ask about people with diabetes who don’t follow their diet or those with heart disease who don’t exercise? In fact, the condition discussed in the Times article is not inherent to drug injecting, and the treatment of it doesn’t require limited resources like transplants do: it’s spread by unsterile syringes, which is a result of lack of access to clean ones, not addiction itself.

Often, stories focus exclusively on people whose use started with a prescription.

It’s important for journalists to understand that criminalization is not some sort of natural fact, and laws are not necessarily made for rational reasons. Our system does not reflect the relative risks of various drugs;legal ones are among the most harmful in terms of their pharmacological effects. With the exception of the legislation that resulted in the creation and maintenance of the FDA, our drug laws were actually born in a series of racist panics that had nothing to do with the relative harms of actual substances.  

In order to do better, journalists must recognize that addiction is not simply a result of exposure to a drug, and that “innocence” isn’t at issue.  The critical risk factors for addiction are child trauma, mental illness, and economic factors like unemployment and poverty. The “innocent victim” narrative focuses on individual choice and ignores these factors, along with the dysfunctional nature of the entire system that determines a drug’s legal status.

The difference between dependence and addiction

Widespread conflation of addiction and dependence further mars opioid coverage.

These days, experts from the National Institute on Drug Abuse and the authors of the Diagnostic and Statistical Manual, now DSM-5, agree that the core of addiction is compulsive drug use that continues regardless of bad outcomes. Unfortunately, from 1987 to 2013, the DSM termed its diagnosis “substance dependence.” This misnomer supported a widespread misconception of “real” addiction as the need for a substance in order to function and avoid getting physically ill, rather than a compulsion that drives behavior.

The critical difference between addiction and dependence becomes clear when you look at specific drugs. Crack cocaine, for example, doesn’t cause severe physical withdrawal symptoms, but it’s one of the most addictive drugs known. Antidepressants like Prozac, meanwhile, don’t produce compulsive craving the way cocaine can, but some have severe withdrawal syndromes.

Needing opioids for pain alone, then, doesn’t meet the criteria for addiction. If the consequences of drug use are positive and the benefits outweigh the harm from side effects, then that use is no different from taking any other daily medication. Dependence in and of itself isn’t a problem unless the drug isn’t working or is more harmful than it is helpful.

Unfortunately, while the scientific understanding has changed to reflect these facts, the press hasn’t caught up. The Washington Post conducted a poll of pain patients on opioids that labeled one third of them as addicted after they responded “yes” to a question that asked whether they were “addicted or dependent,” without defining either term. A CBS affiliate in Chicago talked about treating “opioid dependence” when they actually meant “addiction”; this CNN story has the same problem.  

Needing opioids for pain alone doesn’t meet the criteria for addiction.

This would be a mere semantic issue if it didn’t have such awful effects on policy. Conflating addiction and dependence results in harm to pain patients, children exposed to opioids in utero, and people who take medication to treat addiction.

Any pain patient who takes opioids daily for long enough will develop physical dependence and suffer withdrawal if the medication isn’t tapered slowly. But if either the doctor or the patient sees this dependence as addiction, then the patient is at risk of being cut off from medication that is actually helpful.

In some instances, hundreds or even thousands of patients have been forcibly tapered from opioids in an attempt to comply with federal guidelines and law enforcement pressures, without regard for individual medical circumstances or needs. For instance, Oregon has proposed rules which prohibit Medicaid patients from receiving more than 90 days worth of opioids, period, unless they are dying, and that all who are currently on opioids must stop. But there is no evidence to support cutting off chronic pain patients who are doing well on these medications, and at least one preliminary study associated such a drastic measure with increased risk of suicide while not reducing overdose risk.

To make matters worse, mistaking dependence for addiction also harms people who take treatment medications like methadone or buprenorphine, which are the only two therapies proven to cut the death rate by 50 percent or more.  These medications don’t produce any intoxication once an appropriate and regular dosing schedule is instituted. They relieve the compulsion and the consequences that are the hallmark of addiction.  However, they only work for as long as people stay on the meds—in other words, patients remain dependent.

Sadly, even if patients have gone from being homeless and unemployable to being productive workers, the fact that they are still on medication means that they are often stigmatized as being “not really” in recovery—indeed, if dependence is the same as addiction, they aren’t. This misconception leads many to prematurely stop, often resulting in overdose death.

It’s important for journalists to explain these distinctions—to ensure that both pain patients and people with addiction have access to appropriate medication.

Plus, there’s no such thing as an addicted baby

Perhaps the most insidious product of the media’s failure to distinguish between addiction and dependence is the myth of “addicted babies,” which leads to headlines like “The Tiniest Addicts.” Such a stigma that can do lasting harm to a child:  research from the crack years showed that infants labeled as “crack babies” were seen as having less potential and normal toddler behavior was labeled as pathological.

Infants certainly can experience physical dependence and painful withdrawal as a result; what’s known as “neonatal abstinence syndrome” is the result of withdrawal symptoms following opioid exposure in the womb. However, babies can’t be “born with addiction.” An infant doesn’t know why it feels uncomfortable or what could fix the problem—it has dependence, not addiction

How to change your language, and your coverage

How can journalists do better?  First, be aware of the importance of your language, and explain the differences between key terms to your readers and viewers.

Last year, the AP decided to update its stylebook to address these issues, which provides a useful guide. Journalists are advised to use the phrase “person with addiction” rather than the noun “addict.” “Person first” language is already used routinely for people with other mental illnesses such as schizophrenia and depression; failing to follow best practices for people with addiction suggests it’s not really a legitimate health problem.  

Similarly, just as we no longer use offensive terms like “maniac” to refer to people with bipolar disorder, words like “druggie” and “junkie” should be avoided. The AP urges its members not to conflate addiction and dependence for precisely the reasons listed above, and also warns against using the term “drug abuse”—which, like “dependence,” has been removed from the DSM. “Misuse” is more accurate and less moralistic.

Ask yourself if you are covering addiction the way you would any other medical disorder. Would you rely on police as sources to discuss patients’ behaviors or pharmacology? Would you accept claims about patients that frame them fundamentally dishonest by nature? Would you highlight only “innocent” victims of the disease?

Ask yourself if you are covering addiction the way you would any other medical disorder.

Don’t accept claims about what works in addiction treatment at face value. Ask for research supporting treatment outcomes. If it doesn’t exist, or if there is data on similar programs having poor outcomes, include these facts.

Be as skeptical of claims about work or spiritual cures as you would be for cancer care. The addiction treatment industry simply is not professionalized in the way other health care is. Many treatment providers have little training beyond their own experience with addiction and are not familiar with the research. Don’t give self-interested claims about treatment outcomes or the supposed superiority of self-help groups the same weight as peer-reviewed data—and make sure you include peer-reviewed research whenever you cover medication and behavioral treatment.

Ensure that your audience knows that our system of drug laws is not based on scientific information about drugs. Writing about drugs frequently contains implicit racism;stories framed around the idea that white people with addiction “are not typical” imply that people of color are.

Finally, if you think you know a fact about substance misuse, check it. Some of the best stories come from simply exploring the research that shows that most of what we think we know about drugs is completely wrong.

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Fed up? Fired up? Pharmacy problems? Force tapered?

Posted on August 19, 2018 by Pharmaciststeve

Wanna tell the government how their restrictions are hurting you?

Here’s how: the FDA has asked for our input- a forum where you can tell them how you’ve been affected. And you can do it anonymously. Please, do it for yourself and do it for all of us.

https://www.regulations.gov/docket?D=FDA-2018-N-1621

We only have about two weeks left and we don’t have enough comments submitted yet to make a big impact, so I beg you to take this one chance we have because it won’t happen again.

Steve, thank you again for the work you do for us. I appreciate your consideration. Feel free to message me back if you would like to discuss this further!

Filed under: General Problems | 4 Comments »

Oregon Opioid Forced Taper Debate Continues

Posted on August 18, 2018 by Pharmaciststeve

Oregon Opioid Forced Taper Debate Continues

http://nationalpainreport.com/oregon-opioid-forced-taper-debate-continues-8836964.html

Oregon’s Health Evidence Review Commission’s (HERC) Value based benefits Subcommittee heard testimony from national pain leaders, Oregon physicians and nurses and pain patients during a day long meeting on Thursday.

At issue is the controversial proposal that HERC is considering to force taper Oregon Medicaid patients off opioids in one year. While they are essentially guidelines, HERC calls them a prioritized list policy – HERC dictating how doctors care and prescribe for their medicaid patients, essentially.

The proposal raised the ire of pain patient advocates and medical professionals across the country. HERC’s Chronic Pain Task Force, which developed the guideline, has been asked to meet again on September 20th and consider the testimony heard this week.

Oregon physician Dr. Ginevra Liptan, who opened the nation’s first practice devoted to fibromyalgia was among those who testified—tearfully–against the guideline. Dr. Liptan has had fibromyalgia since she was in medical school at Tufts.

Also testifying against the guideline was Bob Twillman, Ph.D., is the Executive Director for the Academy of Integrative Pain Management. In that capacity, Dr. Twillman is responsible for overseeing federal and state pain policy developments and advocating for those supporting an integrative approach to managing pain.

In addition, two nurses from Oregon, Carolyn Concia and Karen Yeargin added their perspective that the forced taper guideline as constructed would hurt chronic pain patients–many of whom depend on opioid medication in their battle against pain.

Oregon’s chronic pain community showed at the meeting in Wilsonville to let the HERC members know that they believe these guidelines will hurt chronic pain patients. The “protestors” were outside the meeting site early Thursday morning, only to find out the HERC members went in the back door.

Two woman who led the protest, who do not wish to have their names publicized because of fear of recrimination against them and their doctors, labeled the day a “great success”.

They also warned–“the battle continues”.

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#OurPain: The other side of opioids LasVegasNOW KLAS TV8

Posted on August 18, 2018 by Pharmaciststeve

Filed under: General Problems | 4 Comments »

Doug Hughes: As nation cracks down on pill abuse, chronic pain sufferers left to die

Posted on August 18, 2018 by Pharmaciststeve

Doug Hughes: As nation cracks down on pill abuse, chronic pain sufferers left to die

https://www.wvgazettemail.com/opinion/gazette_opinion/op_ed_commentaries/doug-hughes-as-nation-cracks-down-on-pill-abuse-chronic/article_3a6fcd7d-8776-59e9-b8da-d352caa3fba4.html

I have had Chronic Intractable Pain Syndrome for 29 years. For 23 years, I was treated to a functional ability level. Twenty-nine years with no aberrant behavior. I have seen what has gone on, and I need some answers.

When the Centers for Disease Control issued its “Alert” around 2012 that advised doctors to be careful in treating anxiety, sleep disorders, PTSD and depression simultaneously with pain medications, did they think that the embattled pain clinic physicians (the specialists for the complex treatment of Chronic Intractable Pain Syndrome) would do nothing short of stopping all such co-morbid treatment?

The CDC already know that Chronic Intractable Pain Syndrome is co-morbid with these conditions and anything that Valium helps. How many sufferers did that harm? Do they care?

When the Drug Enforcement Agency first forced pain clinics to severely cut pain treatment to all patients, from 2010 to 2016, did anyone think for one moment that it would force legitimate sufferers into low-dose medications?

Did the CDC turn an eye when someone mentioned the most severely injured disabled people in the nation were also having to endure the egregious suffering of under-treatment, souls who were mangled in a car wreck, or crushed in a coal mine, like me?

Did the CDC even flinch when the overdose deaths increased shortly after each pain clinic’s closure? Does anyone care, even a little?

The CDC noted West Virginia as the “Opioid Epidemic’s Epicenter,” but was there any difference between West Virginia and the rest of the nation?

West Virginia leads the nation for decades with the most industrial injuries that caused Chronic Intractable Pain Syndrome. However, the last pain clinic in West Virginia was closed by the DEA on Feb. 22, 2018.

How many people with Chronic Intractable Pain Syndrome with no treatment were forced into self-medicating with street drugs? How many into suicide? Can you say “epicenter”? Is it just apathy?

The DEA cut treatment at all pain clinics, then closed almost all pain clinics and the death rates accelerated. The death rates were accelerated higher by the DEA, and they blamed it on the opioid epidemic.

The CDC issued the 2016 “Guidelines for Prescribing Opioids for Chronic Pain.” What result did they plan by having all “drug control professionals” on that panel? Why did the range of opinions result in the rigid limit of 120 morphine milligram equivalent?

If they had done any research, surely they had to know that patients leaving pain clinic treatment had been consumed by the opioid epidemic. Did the forced under-treatment to the point of suicide not keep anyone up even one night?

The CDC’s last words in the draft Guideline said that “it was in most cases.” Why then, did they issue it without accommodations for legitimate patients of Chronic Intractable Pain Syndrome, patients who had been treated for decades like me, and had never become addicted?

A 2017 study by a WVU professor and an international panel found that suicide deaths in the nation increased 34 percent between 2000 and 2016. They said the type of suicides studied were drug-related suicides that could have been as much as 75 percent listed as “undetermined deaths.” Why was that study not followed up on?

Medicare sent a letter in January 2018 to all doctors treating with “high dose opioid pain medications.” How could anyone know what high doses are, when any of the outstanding chronic pain physicians have been destroyed?

Doctors will not lose their approved Medicare Provider Status by going above the guideline of 120 morphine milligram equivalent (MME).

Did causing a few hundred thousand suicides or overdose deaths of the most disabled in the nation feel good? Did Medicare’s most costly group for lifetime expenditures get decimated? Did someone get credit for service to the fiduciary concerns of Medicare?

Anatomical and physiological diversification among individuals makes standardized treatment for Chronic Intractable Pain Syndrome sufferers a great placebo for those who do not have it. Has “ignorance become confidence,” as the saying goes?

Now with Medicare standardizing pain treatment at the worst estimate of 90 MME on Jan. 1, 2019, will the CDC tell us the limit applies “in most cases,” or will the CDC keep letting people die?

Has anyone been to any funerals for former pain clinic patients who suffered from Chronic Intractable Pain Syndrome and who passed away suddenly?

Is the widespread suffering and dying of the most disabled in the nation a situation to be proud of?

Doug Hughes, of Logan, is a former coal miner and retired from the DEP.

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Chronic Pain Survey Reopened

Posted on August 18, 2018 by Pharmaciststeve

Chronic Pain Survey Reopened

www.nationalpainreport.com/chronic-pain-survey-reopened-8837011.html

By Ed Coghlan.

In a week when the DEA announced it is going further reduce the supply of opioids in 2019, a leading chronic pain activist has reopened her survey of chronic pain patients.

Dr. Terri Lewis pointed that while the argument continues to rage between those who want to strangle the supply of opioids and those who argue that only chronic pain patients are being hurt by the reduced supply, no one is really is talking to or about chronic pain patients.

Her survey, which already has attracted more than 2,000 respondents from across the country, is designed to hear what is happening to the chronic pain patients (and their families) in this war on opioids.

“We are finding out that many people are being negatively impacted in this opioid controversy,” she said. “The results of reducing supply are not reducing opioid overdoses or even deaths from overdoses, but it does seem to be hurting chronic pain patients who use the opioid therapy to manage their conditions.”

Need More Rural Response

Dr. Lewis pointed out that she is trying to get at least 30 respondents from each of the 50 states and has mostly attained that goal. Thus far, only rural states like Montana, Wyoming, the Dakotas, Kansas and Nebraska are under the 30 response minimum, so if you live in those states in particular, we urge you to fill out survey.

Here’s a link to the survey.

“We’ve been developing some interesting in-state data that we are sharing with state leaders and chronic pain advocates which can help them make the case that the states need to create their own pain policies that have patients in mind,” she said.

Meanwhile, the DEA is continuing its efforts to restrict access to more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl.

“We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” said DEA Acting Administrator Uttam Dhillon. “This significant drop in prescriptions by doctors and DEA’s production quota adjustment will continue to reduce the amounts of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine.”
Reducing supply is beginning to reveal the consequences of current regulatory approaches.  Hospitals increasingly report shortages of essential opioids and are resorting to the rationing surgeries, replacing standby medications with less effective alternatives, and implementation of opioid sparing regimens. A recent survey by the American Society of Anesthesiologists (ASA) survey found that 95 percent of those who responded reported that shortages have affected the way they treat their patients.
The top five opioid medications in the shortest supply are hydromorphone(Dilaudid), fentanyl and morphine, the local anesthetic bupivacaine, and the lifesaving allergy drug epinephrine.  Recent efforts by the federal government to curb the opioid crisis — by cutting back on the raw materials used to make opioids — may partly explain why.  Another factor is the delay of production capacity for drug manufacturing plants located in Puerto Rico. 
Notably, many states are reporting that prescriptions are decreasing, overdoses and suicides are increasing, and the drug most correlated to overdoses are heroin and carfentanyl, both imported from abroad.

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Trump administration proposes production quota cuts for six opioids

Posted on August 17, 2018 by Pharmaciststeve

Trump administration proposes production quota cuts for six opioids

https://www.reuters.com/article/us-usa-opioid-manufacturing/trump-administration-proposes-production-quota-cuts-for-six-opioids-idUSKBN1L11XD

WASHINGTON/NEW YORK (Reuters) – The Trump administration on Thursday proposed that U.S. drugmakers cut production quotas of the six most abused opioids by 10 percent next year to fight a nationwide addiction crisis.

In a statement, the U.S. Justice Department and Drug Enforcement Administration (DEA) said the proposed cut would be in keeping with President Donald Trump’s effort to cut opioid prescription fills by one-third within three years.

Trump on Thursday also pressed U.S. Attorney General Jeff Sessions to sue drug manufacturers over the opioid crisis.

“I’d like to bring a federal lawsuit against those companies,” Trump said during a meeting of his Cabinet at the White House. He did not name the companies.

Addiction to opioids – mainly prescription painkillers, heroin and fentanyl – is a growing U.S. problem, especially in rural areas. According to the Centers for Disease Control and Prevention, opioids were involved in more than 49,000 deaths in the country last year.

The Justice Department and the DEA said they are proposing to cut production quotas for oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl by 7 percent to 15 percent, depending on the compound, in 2019.

Hundreds of lawsuits have been filed by states, counties and cities against opioid manufacturers including Purdue Pharmaceuticals LP, Endo International Plc (ENDP.O), Mallinckrodt Plc (MNK.N) and Johnson & Johnson (JNJ.N) seeking to hold them responsible for contributing to the epidemic.

Endo International PLC15.64
ENDP.ONasdaq
-0.31(-1.94%)
ENDP.O
  • ENDP.O
  • MNK.N
  • JNJ.N

Those companies were not immediately available for comment.

In March, Trump unveiled a plan to get tough on opioids, including cutting opioid prescriptions by changing federal programs, funding for other initiatives and stiffer sentencing laws for drug dealers.

He also suggested the death penalty for dealers, a proposal that has gained little support from drug abuse and judicial experts.

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DEA Wants More Marijuana Grown And Fewer Opioids Produced In 2019. Really.

Posted on August 17, 2018 by Pharmaciststeve

DEA Wants More Marijuana Grown And Fewer Opioids Produced In 2019. Really.

https://www.forbes.com/sites/tomangell/2018/08/16/dea-wants-more-marijuana-grown-and-fewer-opioids-produced-in-2019-really/#7359782214cb

The Drug Enforcement Administration (DEA) isn’t exactly known as big fan of marijuana. But in a new Federal Register filing set to be published soon, the anti-drug agency is moving to more than quintuple the amount of cannabis that can legally be grown in the U.S. for research purposes—from roughly 1,000 pounds in 2018 to more than 5,400 pounds next year.

MUJAHID SAFODIEN/AFP/Getty Images

At the same time, DEA is also pushing to reduce the amount of certain opioid drugs—such as oxycodone, hydrocodone, morphine, fentanyl and others—that are produced in the U.S.

“We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” DEA Acting Administrator Uttam Dhillon said in a press release. “This significant drop in prescriptions by doctors and DEA’s production quota adjustment will continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine.”

U.S. Attorney General Jeff Sessions, a longtime opponent of marijuana legalization, added that “the opioid epidemic that we are facing today is the worst drug crisis in American history… Cutting opioid production quotas by an average of ten percent next year will help us continue that progress and make it harder to divert these drugs for abuse.”

The proposed quotas for cannabis and other drugs “reflects the total amount of controlled substances necessary to meet the country’s medical, scientific, research, industrial, and export needs for the year and for the establishment and maintenance of reserve stocks,” DEA said.

The 2,450,000 grams of marijuana the narcotics agency wants grown in the country in 2019 is a significant bump up from the 443,680 grams the agency authorized for 2018.

In addition to the huge increase in marijuana cultivation, DEA is also proposing to allow production of 384,460 grams of tetrahydrocannabinols (THC) in 2019, the same amount the agency cleared for this year.

Since 1968, a farm that the University of Mississippi has maintained a monopoly on the production of cannabis that can legally be used for research in the U.S. But scientists have long complained that it is sometimes hard to get approvals to obtain marijuana from the facility and that its product is often of low quality.

In response to these concerns, DEA moved in the waning months of the Obama administration to end the monopoly and create a process for the National Institute on Drug Abuse (NIDA) to license additional cultivators. But while more than two dozen facilities have filed proposals to become licensed to legally grow marijuana for research, Sessions’ Justice Department has blocked DEA from acting on the applications.

Members of Congress have repeatedly pressed Sessions on the issue, during hearings and most recently in a letter signed last month by eight senators.

“Research and medical communities should have access to research-grade materials to answer questions around marijuana’s efficacy and potential impacts, both positive and adverse,” the lawmakers wrote. “Finalizing the review of applications for marijuana manufacturing will assist in doing just that.”

During a Senate hearing last October, Sessions said that adding new facilities that could compete with the University of Mississippi would be “healthy.” Pressed again in April, he told senators that movement on the issue was expected “soon.”

But no announcements on authorizing more cultivators have been made.

The DEA’s huge increase in marijuana production quotas for 2019 could be a sign that it anticipates eventual approval of some of the additional grower applications, or it could just indicate that reserve stocks at the Mississippi farm are getting low and that it’s time to re-up the federal cannabis stash as interest in marijuana’s medical benefits and other effects increases among the public and scientists who wish to study it.

“While the drastic increase in requested production of marijuana by the DEA is a positive sign, significant barriers still exist including but not limited to the NIDA monopoly on cultivation and undue hurdles for researchers to qualify for a permit,” NORML Political Director Justin Strekal in an interview. “It’s time that Congress look at the 28,000 plus peer-reviewed studies currently hosted on the National Institute of Health’s online database and reform federal law by removing marijuana from the Controlled Substances Act all together.”

Once the DEA quota notice officially runs in the Federal Register, members of the public will be able to submit comments for a period of 30 days, after which time the agency may seek to amend and finalize the proposal.

Tom Angell publishes Marijuana Moment news and founded the nonprofit Marijuana Majority. Follow Tom on Twitter for breaking news and subscribe to his daily newsletter.

I’m a 15-year veteran of the cannabis law reform movement, and I know where to look to spot the most interesting legalization developments. I’m the editor of the cannabis news site Marijuana Moment, and I founded the nonprofit Marijuana Majority. Follow me on Twitter

Here is the DEA’S definition of a C-I drug under the Controlled Substance Act;

Schedule I Controlled Substances

Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.

Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (“Ecstasy”).

That was the DEA’S opinion back in 1970… should “opinions” become “legal facts”… now the DEA has decided that it wants more RESEARCH to prove or disprove this opinion/fact after nearly 50 yrs ?  Could it be that after over HALF of our states have legalized Marijuana in some form… the DEA has been forced to do research to try and validate that their “facts” of 50 yrs ago was correct and what is going to happen if they are proven wrong ?

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Thyroid medication recalled: Chinese manufacturer’s failed inspection leads to recall

Posted on August 16, 2018 by Pharmaciststeve

https://www.cnbc.com/2018/08/16/thyroid-meds-chinese-manufacture-fails-inspection-leads-to-recall.html

A medication used to treat hypothyroidism has been voluntarily recalled due to quality concerns.

Westminster Pharmaceuticals, LLC has instructed wholesalers to stop distributing specific products labeled “Levothyroxine and Liothyronine (Thyroid Tablets, USP),” according to an August 9 release. Levothyroxine and Liothyronine are synthetic hormones contained in the thyroid tablets.

The voluntary national recall alert says there have been no “adverse events” associated with the recalled products. It says patients should continue taking the drugs.

“Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product,” the release says.

More than 4.5 percent of the U.S. population over the age of 12 suffers from an underactive thyroid or hypothyroidism, according to the National Library of Medicine’s MedlinePlus.

The release instructs patients to speak with their physician before discontinuing use of the medicine.

The recall follows a June 22 warning letter from the Food & Drug Administration to a Chinese pharmaceutical company which manufactured active ingredients in the recalled drug. The letter cited a number of failures, including ones relating to “established standards of quality and purity.”

The recall alert says issues cited in that warning letter “could represent the possibility of risk being introduced into the manufacturing process.”

A full list of recalled products is available from the FDA.

Patients with questions or information about an issue relating to the recalled products can contact Westminster at: 888-354-9939.

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